Hello - looking for real-world experience with the PMA process and advisory committee/panel reviews (Class III device). I understand it differs across FDA divisions but hoping I can pull some examples from this group to help with realistic planning.
1) When does the advisory panel usually occur - after FDA has completed their 180 day review of the PMA, shortly after the 90-day substantive interaction (e.g. deficiency letter) or sometime before the 180-day clock runs out?
2) How many "FDA days" in your PMA with panel review cycle? (how many days did FDA use of the total review time from acceptance review to FDA decision)
3) Does FDA typically take the 60-days they are allowed after the panel meeting to make a final PMA decision?
Thank you, all!
1) When does the advisory panel usually occur - after FDA has completed their 180 day review of the PMA, shortly after the 90-day substantive interaction (e.g. deficiency letter) or sometime before the 180-day clock runs out?
2) How many "FDA days" in your PMA with panel review cycle? (how many days did FDA use of the total review time from acceptance review to FDA decision)
3) Does FDA typically take the 60-days they are allowed after the panel meeting to make a final PMA decision?
Thank you, all!
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